Parents Not Told of Danger to Premature Babies

A study in 1,316 premature infants has drawn a reprimand from U.S. officials who say the children’s parents weren’t adequately advised of “reasonably foreseeable risks,” including blindness and death.

The Department of Health and Human Services, in a letter dated March 7, said a research team led by Richard Marchase at the University of Alabama at Birmingham “failed to adequately inform parents of the reasonably foreseeable risks and discomforts of research participation.”

In the study, infants were assigned to receive different levels of oxygen to determine their reaction to high amounts, which had been tied to blindness, or low amounts, connected to a higher risk of death. The department’s letter was made public yesterday by Public Citizen, a watchdog group that criticized the HHS response as insufficient because it didn’t include 22 other medical centers involved in the study or an apology to the families of children studied.

“The word ‘unethical’ doesn’t even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study,” Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement.

The Public Citizen communication, sent to Health and Human Services Secretary Kathleen Sebelius, urged the agency to review other research on premature babies for similar breaches and investigate how its oversight of clinical trials failed in this case in order to prevent future mistakes.

The research sought to determine the ideal balance between the survival benefit for premature babies who received high levels of oxygen and their risk of a form of blindness linked to premature birth. The infants in the study were born from 24 weeks to 28 weeks of gestation. Newborns are considered to be full term after 40 weeks.

The study funded by the National Institutes of Health was carried out from 2005 to 2009. The amount of oxygen given was within the range commonly used to treat premature infants at the time. Doctors until then guessed the best level for each baby based on their understanding of earlier research and personal experience.

The infants who participated in the study were less likely to die than babies at the same institutions who weren’t in the trial, regardless of how much oxygen they received, Marchase said yesterday in a statement. The mortality rates were also lower than expected based on historical levels, he said.

The HHS criticism centered on the consent forms and the way they outlined the possible risks to infants, he said. There were no complaints about the medical approach, Marchase said. Physicians involved in the research at all 23 medical centers worked together to craft the consent form, which was approved by all their institutional review boards, he said.

Carome, Public Citizen’s deputy director, served on the HHS Office of Human Research Protections staff for 10 years before joining the government watchdog group. If the parents had known of the risks, it is likely “many, if not most, parents would not have allowed their babies to be in this study,” Public Citizen said in its statement.